Major Depressive DisorderPhase 2CIT-PINNCT00931775
Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder
A Phase 2 study testing Pindolol in people with Major Depressive Disorder and Antidepressant Treatment Response, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Antidepressant Treatment Response
- What is being tested?
- Pindolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2002to Nov 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a depressive episode
- HDRS score > 18
- Written informed consent
Who cannot join
- suicidal risk > 3
- severe organic illness
- other psychotropic drugs
Trial locations and contacts
1 site in 1 country.
Spain1 site
Outpatients Service of Psychiatry Department. Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025
About this study
Official title: Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder
The purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.
Read the detailed description
Design, Settings, and Participants. A randomised, double-blind, placebo-controlled trial with MDD patients allocated to two treatment arms: citalopram + pindolol versus citalopram + placebo. Participants: outpatients with a depressive episode (DSM-IV criteria) were selected from a general hospital.
- Being tested
- Pindolol
- Keywords
- Major depressive disorder, citalopram, pindolol, HDRS
- Medical subject headings
- Depressive Disorder, Major, Barakat syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PindololDrug
Pill orally administered. 15 mg/day t.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Citalopram + placebo | Placebo comparator | Citalopram 20 mg/day t.i.d Receives: Drug: Pindolol |
| Citalopram + pindolol | Experimental | Citalopram 20 mg/day t.i.d Pindolol 15 mg/day t.i.d. Receives: Drug: Pindolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on Hamilton Depression Rating Scale
Measured: 8 time points through 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startDec 2002
- Primary completionMar 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Enric Álvarez, MD, PhD, Principal investigator, Department of Psychiatry. Hospital de la Santa Creu i Sant PauVíctor Pérez, MD, PhD, Study director, Department of Psychiatry. Hospital de la Santa Creu i Sant PauFrancesc Artigas, PhD, Study chair, Neurochemistry department. Consejo Superior de Investigaciones Científicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931775
- Sponsor's protocol ID
- CIT-PIN_01-0C3
- Acronym
- CIT-PIN
- Status last verified
- Jul 2009
- First submitted
- 1 Jul 2009
- Last updated
- 2 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Portella MJ, de Diego-Adelino J, Ballesteros J, Puigdemont D, Oller S, Santos B, Alvarez E, Artigas F, Perez V. Can we really accelerate and enhance the selective serotonin reuptake inhibitor antidepressant effect? A randomized clinical trial and a meta-analysis of pindolol in nonresistant depression. J Clin Psychiatry. 2011 Jul;72(7):962-9. doi: 10.4088/JCP.09m05827blu. Epub 2010 Oct 19.
PubMed 21034693
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00931775
- Acronym / sponsor ID
- CIT-PIN / CIT-PIN_01-0C3
- Keywords
- Major depressive disorder, citalopram, pindolol, HDRS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Mar 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.
Detailed description
Design, Settings, and Participants. A randomised, double-blind, placebo-controlled trial with MDD patients allocated to two treatment arms: citalopram + pindolol versus citalopram + placebo. Participants: outpatients with a depressive episode (DSM-IV criteria) were selected from a general hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram + placebo | Placebo comparator | Drug: PindololCitalopram 20 mg/day t.i.d |
| Citalopram + pindolol | Experimental | Drug: PindololCitalopram 20 mg/day t.i.d Pindolol 15 mg/day t.i.d. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a depressive episode
- HDRS score > 18
- Written informed consent
Key exclusion criteria (3 listed)
- suicidal risk > 3
- severe organic illness
- other psychotropic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PindololPill orally administered. 15 mg/day t.i.d. | Drug | Citalopram + pindolol, Citalopram + placebo |
Primary outcome
Scores on Hamilton Depression Rating Scale
Time frame: 8 time points through 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2009.
- Derived from this study: PubMed 21034693Portella MJ, de Diego-Adelino J, Ballesteros J, Puigdemont D, Oller S, Santos B, Alvarez E, Artigas F, Perez V. Can we really accelerate and enhance the selective serotonin reuptake inhibitor antidepressant effect? A randomized clinical trial and a meta-analysis of pindolol in nonresistant depression. J Clin Psychiatry. 2011 Jul;72(7):962-9. doi: 10.4088/JCP.09m05827blu. Epub 2010 Oct 19.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enric Álvarez, MD, PhD principal investigator
Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
Víctor Pérez, MD, PhD study director
Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
Francesc Artigas, PhD study chair
Neurochemistry department. Consejo Superior de Investigaciones Científicas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pindolol in people with Major Depressive Disorder and Antidepressant Treatment Response, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on Hamilton Depression Rating Scale (time frame: 8 time points through 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00931775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2009.